A Phase 3 interventional study of albiglutide and insulin glargine in Diabetes Mellitus, Type 2, sponsored by GlaxoSmithKline. Completed at 338 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-09.
Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Treatment
A study to determine the safety and efficacy of albiglutide in subjects with type 2 diabetes.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 779 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →GlaxoSmithKline is the lead sponsor of 3,562 studies on the registry; 117 are open to participants now.
Of its 258 completed or terminated interventional studies of FDA-regulated products, 232 (90%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
albiglutide weekly subcutaneous injection
Biological: albiglutide
insulin glargine daily injection
Drug: insulin glargine
albiglutide weekly injection
insulin glargine
Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The BL HbA1c value is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 52 minus the value at BL. Based on analysis of covariance (ANCOVA): change = treatment + BL HbA1c + prior myocardial infarction history + age category + region + current antidiabetic therapy. Difference of least squares means (albiglutide - insulin glargine) is from the ANCOVA model. The last observation carried forward (LOCF) method was used to impute missing post-Baseline HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values.
Time frame: Baseline and Week 52
Change From Baseline in HbA1c at Week 156
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed HbA1c values, excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.
Time frame: Baseline and Week 156
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52
The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. FPG values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on ANCOVA: change = treatment + Baseline FPG + Baseline HbA1c category + prior myocardial infarction history + age category + region + current antidiabetic therapy.
Time frame: Baseline and Week 52
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 156
The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline and Week 156
Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 52
The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of \<6.5%, \<7%, and \<7.5% at Week 52) were assessed.
Time frame: Week 52
Number of Participants Who Achieved Clinically Meaningful HbA1c Response Levels of <6.5%, <7%, and <7.5% at Week 156
The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of \<6.5%, \<7%, and \<7.5% at Week 156) were assessed.
Time frame: Week 156
Time to Hyperglycemia Rescue
Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: FPG \>=280 milligrams/deciliter (mg/dL) between \>=Week 2 and \<Week 4; FPG \>=250 mg/dL between \>=Week 4 and \<Week 12; HbA1c \>=8.5% and a \<=0.5% reduction from Baseline between \>=Week 12 and \<Week 24; HbA1c \>=8.5% between \>=Week 24 and \<Week 48; HbA1c \>=8.0% between \>= Week 48 and \<Week 156. Participants could have been rescued at any time on or after Week 2. Time to hyperglycemia rescue is defined as the time between the date of the first dose of study medication and the date of hyperglycemia rescue plus 1 day, or the time between the date of the first dose of study medication and the date of the last visit during the active treatment period plus 1 day for participants not requiring rescue. This time was divided by 7 to express the result in weeks.
Time frame: From the start of study medication until the end of the treatment (up to Week 156)
Change From Baseline in Body Weight at Week 52
The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with prerescue values. Based on ANCOVA: change = treatment + Baseline weight + Baseline HbA1c category + prior myocardial infarction history + age category + region + current antidiabetic therapy.
Time frame: Baseline and Week 52
Change From Baseline in Body Weight at Week 156
The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight.
Time frame: Baseline and Week 156
Change From Baseline in Glucose Profile Measured by 24-hour Area Under Curve (AUC) at Week 52
A 24-hour glucose profile was collected at Baseline and Week 52 at a subset of sites in a subset of participants per treatment group using the continuous glucose monitoring device. Glucose measurements were obtained at 5 minute increments in the 24-hour period. The area under the curve (AUC) was determined using the trapezoidal method on the measurements obtained during the first 24 hours of continuous monitoring. This analysis used observed values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed. The Baseline value is the last non-missing value before the start of treatment.
Time frame: Baseline and Week 52
Albiglutide Plasma Concentrations at Week 8 and Week 24
Albiglutide plasma concentration data was analyzed at Week 8 pre-dose, Week 8 post-dose, Week 24 pre-dose and Week 24 post-dose. All participants receiving albiglutide were initiated on a 30 mg weekly dosing regimen; however, beginning at Week 4, uptitration of albiglutide was allowed based on glycemic response. As such, albiglutide plasma concentrations achieved at each sampling time represent a mixed population of participants receiving either 30 mg or 50 mg weekly for various durations.
Time frame: Weeks 8 and 24
| Milestone | Albiglutide 30 mg + Metformin +/- Sulfonylurea | Insulin Glargine 10 Units + Metformin +/- Sulfonylurea |
|---|---|---|
| Started | 504 | 241 |
| Completed | 308 | 164 |
| Not completed | 196 | 77 |
| Withdrew: Adverse event | 50 | 11 |
| Withdrew: Protocol violation | 12 | 3 |
| Withdrew: Noncompliance | 21 | 14 |
| Withdrew: Severe or repeated hypoglycaemia | 1 | 0 |
| Withdrew: Lost to follow-up | 19 | 18 |
| Withdrew: Withdrawal by subject | 81 | 29 |
| Withdrew: Physician decision | 6 | 1 |
| Withdrew: Termination of study/site by gsk | 1 | 0 |
| Withdrew: Missing | 3 | 1 |
| Withdrew: Pregnancy | 2 | 0 |
| Milestone | Albiglutide 30 mg + Metformin +/- Sulfonylurea | Insulin Glargine 10 Units + Metformin +/- Sulfonylurea |
|---|---|---|
| Started | 504 | 241 |
| Completed | 408 | 190 |
| Not completed | 96 | 51 |
| Withdrew: Adverse event | 10 | 5 |
| Withdrew: Noncompliance | 6 | 5 |
| Withdrew: Lost to follow-up | 38 | 22 |
| Withdrew: Did not enter follow-up period | 7 | 7 |
| Withdrew: Withdrawn from follow-up participation | 26 | 12 |
| Withdrew: Physician decision | 2 | 0 |
| Withdrew: Termination of study/site by gsk | 2 | 0 |
| Withdrew: Withdrawal by subject | 2 | 0 |
| Withdrew: Missing | 3 | 0 |
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The BL HbA1c value is defined as the last non-missing value before the start of treatment. Change from BL was calculated as the value at Week 52 minus the value at BL. Based on analysis of covariance (ANCOVA): change = treatment + BL HbA1c + prior myocardial infarction history + age category + region + current antidiabetic therapy. Difference of least squares means (albiglutide - insulin glargine) is from the ANCOVA model. The last observation carried forward (LOCF) method was used to impute missing post-Baseline HbA1c values; the last non-missing post-BL on-treatment measurement was used to impute the missing measurement. HbA1c values obtained after hyperglycemic rescue were treated as missing and were replaced with pre-rescue values.
| Percentage of HbA1c in the blood | Albiglutide 30 mg + Metformin +/- Sulfonylurea | Insulin Glargine 10 Units + Metformin +/- Sulfonylurea |
|---|---|---|
| Change From Baseline (BL) in Glycosylated Hemoglobin (HbA1c) at Week 52 | -0.67 ± 0.044 | -0.79 ± 0.064 |
HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. Baseline HbA1c value is defined as the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. This analysis used observed HbA1c values, excluding those obtained after hyperglycemia rescue; no missing data imputation was performed.
| Percentage of HbA1c in the blood | Albiglutide 30 mg + Metformin +/- Sulfonylurea | Insulin Glargine 10 Units + Metformin +/- Sulfonylurea |
|---|---|---|
| Change From Baseline in HbA1c at Week 156 | -0.83 ± 0.980 | -1.00 ± 0.922 |
The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. The LOCF method was used to impute missing post-Baseline FPG values. FPG values obtained after hyperglycemia rescue were treated as missing and replaced with pre-rescue values. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Based on ANCOVA: change = treatment + Baseline FPG + Baseline HbA1c category + prior myocardial infarction history + age category + region + current antidiabetic therapy.
| Millimoles per liter (mmol/L) | Albiglutide 30 mg + Metformin +/- Sulfonylurea | Insulin Glargine 10 Units + Metformin +/- Sulfonylurea |
|---|---|---|
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 52 | -0.87 ± 0.127 | -2.06 ± 0.184 |
The FPG test measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. The Baseline FPG value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
| Millimoles per liter (mmol/L) | Albiglutide 30 mg + Metformin +/- Sulfonylurea | Insulin Glargine 10 Units + Metformin +/- Sulfonylurea |
|---|---|---|
| Change From Baseline in Fasting Plasma Glucose (FPG) at Week 156 | -0.83 ± 2.803 | -2.19 ± 3.420 |
The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of \<6.5%, \<7%, and \<7.5% at Week 52) were assessed.
| Participants | Albiglutide 30 mg + Metformin +/- Sulfonylurea | Insulin Glargine 10 Units + Metformin +/- Sulfonylurea |
|---|---|---|
| HbA1c <6.5% | 54 | 25 |
| HbA1c <7% | 156 | 78 |
| HbA1c <7.5% | 268 | 135 |
The number of participants who achieved the HbA1c treatment goal (i.e., HbA1c response levels of \<6.5%, \<7%, and \<7.5% at Week 156) were assessed.
| Participants | Albiglutide 30 mg + Metformin +/- Sulfonylurea | Insulin Glargine 10 Units + Metformin +/- Sulfonylurea |
|---|---|---|
| HbA1c <6.5% | 33 | 18 |
| HbA1c <7% | 59 | 46 |
| HbA1c <7.5% | 85 | 71 |
Participants who experienced persistent hyperglycemia (high blood glucose) could have qualified for hyperglycemia rescue. The conditions for hyperglycemia rescue were as follows: FPG \>=280 milligrams/deciliter (mg/dL) between \>=Week 2 and \<Week 4; FPG \>=250 mg/dL between \>=Week 4 and \<Week 12; HbA1c \>=8.5% and a \<=0.5% reduction from Baseline between \>=Week 12 and \<Week 24; HbA1c \>=8.5% between \>=Week 24 and \<Week 48; HbA1c \>=8.0% between \>= Week 48 and \<Week 156. Participants could have been rescued at any time on or after Week 2. Time to hyperglycemia rescue is defined as the time between the date of the first dose of study medication and the date of hyperglycemia rescue plus 1 day, or the time between the date of the first dose of study medication and the date of the last visit during the active treatment period plus 1 day for participants not requiring rescue. This time was divided by 7 to express the result in weeks.
| Weeks | Albiglutide 30 mg + Metformin +/- Sulfonylurea | Insulin Glargine 10 Units + Metformin +/- Sulfonylurea |
|---|---|---|
| Time to Hyperglycemia Rescue | 107.57 (96.43 to 143.43) | NA (NA to NA) |
The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight. The LOCF method was used to impute missing post-Baseline weight values. Weight values obtained after hyperglycemia rescue were treated as missing and replaced with prerescue values. Based on ANCOVA: change = treatment + Baseline weight + Baseline HbA1c category + prior myocardial infarction history + age category + region + current antidiabetic therapy.
| Kilograms | Albiglutide 30 mg + Metformin +/- Sulfonylurea | Insulin Glargine 10 Units + Metformin +/- Sulfonylurea |
|---|---|---|
| Change From Baseline in Body Weight at Week 52 | -1.05 ± 0.171 | 1.56 ± 0.247 |
The Baseline value is the last non-missing value before the start of treatment. Change from Baseline was calculated as the post-Baseline weight minus the Baseline weight.
| Kilograms | Albiglutide 30 mg + Metformin +/- Sulfonylurea | Insulin Glargine 10 Units + Metformin +/- Sulfonylurea |
|---|---|---|
| Change From Baseline in Body Weight at Week 156 | -3.47 ± 6.300 | 0.90 ± 4.890 |
A 24-hour glucose profile was collected at Baseline and Week 52 at a subset of sites in a subset of participants per treatment group using the continuous glucose monitoring device. Glucose measurements were obtained at 5 minute increments in the 24-hour period. The area under the curve (AUC) was determined using the trapezoidal method on the measurements obtained during the first 24 hours of continuous monitoring. This analysis used observed values excluding those obtained after hyperglycemia rescue; no missing data imputation was performed. The Baseline value is the last non-missing value before the start of treatment.
| Millimoles per hour per liter (mmol.h/L) | Albiglutide 30 mg + Metformin +/- Sulfonylurea | Insulin Glargine 10 Units + Metformin +/- Sulfonylurea |
|---|---|---|
| Change From Baseline in Glucose Profile Measured by 24-hour Area Under Curve (AUC) at Week 52 | 0.457 ± 2.9898 | -1.657 ± 1.9453 |
Albiglutide plasma concentration data was analyzed at Week 8 pre-dose, Week 8 post-dose, Week 24 pre-dose and Week 24 post-dose. All participants receiving albiglutide were initiated on a 30 mg weekly dosing regimen; however, beginning at Week 4, uptitration of albiglutide was allowed based on glycemic response. As such, albiglutide plasma concentrations achieved at each sampling time represent a mixed population of participants receiving either 30 mg or 50 mg weekly for various durations.
| nanograms/milliliter (ng/mL) | Albiglutide 30 mg + Metformin +/- Sulfonylurea |
|---|---|
| Week 8, Pre-dose, n=408 | 1642.83 ± 892.570 |
| Week 8, Post-dose, n=398 | 1911.35 ± 966.180 |
| Week 24, Pre-dose, n=416 | 2159.30 ± 1211.714 |
| Week 24, Post-dose, n=401 | 2748.15 ± 1503.945 |
Collected over On-treatment serious adverse events (SAEs) and non-serious AEs, defined as those events that had a start date on or after the first day of study medication and within 56 days after the end of study medication (up to Week 156), are reported.. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Albiglutide 30 mg + Metformin +/- Sulfonylurea | — | 92/504 (18.3%) | 429/504 (85.1%) |
| Insulin Glargine 10 Units + Metformin +/- Sulfonylurea | — | 46/241 (19.1%) | 199/241 (82.6%) |
| Event | Albiglutide 30 mg + Metformin +/- Sulfonylurea | Insulin Glargine 10 Units + Metformin +/- Sulfonylurea |
|---|---|---|
| Chest painGeneral disorders | 5/504 | 4/241 |
| Angina unstableCardiac disorders | 2/504 | 3/241 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 2/504 | 3/241 |
| Cholecystitis AcuteHepatobiliary disorders | 0/504 | 3/241 |
| Coronary artery diseaseCardiac disorders | 5/504 | 2/241 |
| CellulitisInfections and infestations | 1/504 | 2/241 |
| DiverticulitisInfections and infestations | 0/504 | 2/241 |
| Urinary tract infectionInfections and infestations | 0/504 | 2/241 |
| Acute myocardial infarctionCardiac disorders | 3/504 | 2/241 |
| Cardiac failure congestiveCardiac disorders | 2/504 | 2/241 |
| Event | Albiglutide 30 mg + Metformin +/- Sulfonylurea | Insulin Glargine 10 Units + Metformin +/- Sulfonylurea |
|---|---|---|
| HypoglycaemiaMetabolism and nutrition disorders | 187/504 | 117/241 |
| Upper respiratory tract infectionInfections and infestations | 83/504 | 37/241 |
| NauseaGastrointestinal disorders | 67/504 | 18/241 |
| HypertensionVascular disorders | 67/504 | 29/241 |
| CoughRespiratory, thoracic and mediastinal disorders | 39/504 | 29/241 |
| BronchitisInfections and infestations | 44/504 | 27/241 |
| NasopharyngitisInfections and infestations | 55/504 | 24/241 |
| DiarrhoeaGastrointestinal disorders | 55/504 | 19/241 |
| SinusitisInfections and infestations | 50/504 | 23/241 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 50/504 | 17/241 |
| Age, Continuous(Years) | Albiglutide 30 mg + Metformin +/- Sulfonylurea | Insulin Glargine 10 Units + Metformin +/- Sulfonylurea | Total |
|---|---|---|---|
| Mean | 55.8 ± 9.33 | 54.7 ± 9.75 | 55.5 ± 9.48 |
| Gender(Participants) | Albiglutide 30 mg + Metformin +/- Sulfonylurea | Insulin Glargine 10 Units + Metformin +/- Sulfonylurea | Total |
|---|---|---|---|
| Female | 218 | 109 | 327 |
| Male | 286 | 132 | 418 |
| Race/Ethnicity, Customized(Participants) | Albiglutide 30 mg + Metformin +/- Sulfonylurea | Insulin Glargine 10 Units + Metformin +/- Sulfonylurea | Total |
|---|---|---|---|
| African American/African Heritage | 130 | 64 | 194 |
| American Indian or Alaskan Native | 3 | 1 | 4 |
| Asian - Central/South Asian Heritage | 7 | 5 | 12 |
| Asian - East Asian Heritage | 2 | 1 | 3 |
| Asian - Japanese Heritage | 0 | 1 | 1 |
| Asian - South East Asian Heritage | 16 | 8 | 24 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| White - Arabic/North African Heritage | 7 | 2 | 9 |
| White - White/Caucasian/European Heritage | 342 | 158 | 500 |
| Other - Central American Indian | 1 | 0 | 1 |
| Other - Hispanic | 0 | 1 | 1 |
| Other - Mexican | 1 | 0 | 1 |
Showing the first 100 of 338 sites across 4 countries.
Plan to share: Yes — Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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